MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-25 for MIST THERAPY SYSTEM CP-80004 manufactured by Celleration, Inc..
[805229]
Physical therapist touched the tip of the transducer intentionally, when she noticed that there was no saline coming out of the applicator. She received a friction burn to her fingertip, but has had no complications as a result of the burn.
Patient Sequence No: 1, Text Type: D, B5
[8089426]
This report was delayed due to sales rep not communicating with the manufacturer's complaint coordinator in a timely fashion. Review of reporting time frames was done with sales rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004580659-2008-00001 |
| MDR Report Key | 988826 |
| Report Source | 07 |
| Date Received | 2008-01-25 |
| Date of Report | 2008-01-25 |
| Date of Event | 2007-12-03 |
| Date Mfgr Received | 2007-12-03 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2008-04-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHY SIMPSON, CONSULTANT |
| Manufacturer Street | 10250 VALLEY VIEW ROAD SUITE 137 |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522248700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIST THERAPY SYSTEM |
| Generic Name | NONE |
| Product Code | NRB |
| Date Received | 2008-01-25 |
| Catalog Number | CP-80004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 989872 |
| Manufacturer | CELLERATION, INC. |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-25 |